MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE HEAVY DUTY LONG, OFFSET (77.6 X 0.77 X 11.2MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0277096325
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.D4: full udi is not available due to missing information, unknown lot number.
Event or Problem Description
It was reported that during a procedure, the blade broke.It was further reported that the patient suffered a cut artery, which required a blood transfusion.It was also reported that a new blade was used to complete the procedure without any issues.
Additional Manufacturer Narrative
H2: device evaluation, catalog number received.D4: full udi is not available due to missing lot number.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure, the blade broke.It was further reported that the patient suffered a cut artery, which required a blood transfusion.It was also reported that a new blade was use to complete the procedure without any issues.

• Brand Name: RECIPROCATING BLADE HEAVY DUTY LONG, OFFSET (77.6 X 0.77 X 11.2MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 20590704
• Report Number: 3015967359-2024-02293
• Device Sequence Number: 18339962
• Product Code: GFA
• UDI-Device Identifier: 04546540051783
• UDI-Public: (01)04546540051783
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0277096325
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown